The article provides an overview of the regulatory requirements for certain types of medical devices in line with the 510(k) premarket notification pathway.

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to peripheral percutaneous transluminal angioplasty (PTA) and specialty catheters. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be taken into consideration by medical device manufacturers and other parties involved. At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing regulatory framework and has been agreed with the authority in advance. The present document constitutes a final version of the guidance based on the draft issued by the authority earlier in April. The document represents the current thinking of the authority and could be subject to changes, should such changes be reasonably necessary to reflect corresponding changes to the underlying regulations. 

The scope of the guidance covers the regulatory matters related to PTA balloons and specialty catheters as the products intended to treat lesions in the peripheral vasculature. In particular, the guidance outlines anatomy-specific recommendations to be followed by medical device manufacturers in terms of testing. The document aims to facilitate and streamline the regulatory procedures associated with placing such products on the market. 

The document also references the FDA-recognized voluntary consensus standards medical device manufacturers may refer to demonstrate compliance with the relevant regulatory requirements.

Regulatory Background

The approach described in the guidance is in line with the general rules and principles of the 510(k) premarket notification framework, whereby in order to be allowed to place a new product on the country’s market, its manufacturer should demonstrate substantial equivalence to a similar product already placed on the market (predicate). The substantial equivalence could be demonstrated by providing a side-to-side comparison (usually in the form of a table) clearly stating that the new product is equivalent to the existing one when it takes to safety, quality, and effectiveness when used for its intended purpose. 

Recommendations provided in the guidance are applicable to the following products:

  • Continuous Flush Catheter (product code KRA);
  • Percutaneous Catheter (product code DQY);
  • Peripheral Transluminal Angioplasty Catheter (product code LIT); and
  • Percutaneous Cutting/Scoring Catheter (product code PNO). 

In accordance with the existing framework, the abovementioned medical devices are subject to regulation as Class II medical devices. The authority additionally emphasizes that the matters related to drug-coated balloons fall outside the scope of the present guidance since, due to additional risks associated thereto, such products are regulated as Class III medical devices. 

Premarket Submission Recommendations: Key Points

The document further provides specific recommendations to be considered by medical device manufacturers when applying for marketing approval to ensure the completeness of the respective submissions and facilitate the review process in general. 

For this purpose, the authority describes in detail the scope of information to be included in the submission to the extent necessary for the FDA to conduct its review. According to the guidance, apart from the regulation number and product code, the authority expects the applicant to include the details related to:

  • Device components and mode of operation;
  • Photograph and engineering drawing(s) of the device;
  • Technological characteristics;
  • Materials. 

The document provides additional clarifications regarding the scope of information to be included with respect to each of the above categories. 

Predicate Comparison

Apart from highlighting the key points to be addressed in the marketing submission, the authority also describes the approach for predicate comparison. As it was mentioned before, when applying for marketing approval under the 510(k) premarket notification pathway, medical device manufacturers should provide a detailed enough comparison to a similar medical device already placed on the market and allowed for marketing and use in the country in order to support the substantial equivalence. In particular, the applicant should demonstrate how the new device is similar to and different from the predicate. In order to assist the applicants with complying with the abovementioned requirement, the authority provides an example of the table illustrating the way such a comparison could be structured.


Another important aspect addressed in the guidance is biocompatibility. Since the products covered by the scope of the guidance contain patient-contacting elements, it is vitally important to ensure any and all materials that are expected to be in contact with the patient’s body are safe when the device is used for its intended purpose, and will not cause a harmful biological response. In this respect, the authority states that the manufacturer should determine the biocompatibility of all patient-contacting materials present in the device; if the device is identical in composition, manufacturing, and processing methods to any PTA balloon catheters or specialty catheters with a history of safe use, [the manufacturer] may reference previous testing experience or literature, if appropriate. In certain cases, it could be reasonable to provide references to the applicable consensus standards recognized by the authority.

In summary, the present FDA guidance describes the approach to be applied with respect to PTA balloon catheters intended to be marketed and used in the US. The document highlights the key points to be considered by medical device manufacturers to ensure completeness of the respective submissions and facilitate the regulatory procedures associated thereto.

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